March 30, 2007 -- In a surprise move, a FDA advisory committee yesterday recommended approval of the cancer immunotherapy Provenge from Dendreon. The drug treats prostate cancer, but it missed its endpoint in a Phase III trial, which was to extend the time-to-progression in prostate cancer patients whose disease did not respond to hormone therapy. A subsequent analysis showed that the drug extended median survival by 4.5 months, raising it to 25.9 months from 21.4 months. The result was statistically significant, though the trial, which enrolled just 127 patients, was small. The news sent Dendreon soaring; its stock opened with a triple at $18 per share. More details...
